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07-05-2020 | FDA | News

approvalsWatch

Metastatic TNBC treatment receives FDA nod

Author:
Lynda Williams

medwireNews: Sacituzumab govitecan has been given accelerated approval from the US FDA for the treatment of metastatic triple-negative breast cancer (TNBC) in patients who have received at least two prior therapies.

Sacituzumab govitecan is a Trop-2-directed antibody conjugated to SN-38, an active metabolite of the topoisomerase I inhibitor irinotecan. The agent showed efficacy in the IMMU-132-01 trial of heavily treated TNBC patients; a third of participants achieved an objective response to treatment, and this lasted 6 months or longer in over half of the responders.

The recommended dose of sacituzumab govitecan is 10 mg/kg given as an intravenous infusion on days 1 and 8 of a continuous 21-day treatment cycle and adverse events associated with treatment include a warning for severe neutropenia and diarrhea.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group

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